A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects
NCT02813798
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Female subjects of non-childbearing potential or male subjects
- Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
- Stable renal function
- A positive urine drug screen for illicit drugs
- Treatment with an investigational drug within 30 days of the dose of study medication
- Pregnant females, breastfeeding female subjects and male subjects with partners
currently pregnant
- Use of herbal supplements in the 28 days prior to the dose of study medication
- Blood donation (excluding plasma donation) of approximately 1 pint or more within 56
days prior to study medication
- Requiring dialysis
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Descriptive Information | |||||
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Brief Title ICMJE | A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects | ||||
Official Title ICMJE | A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE DOSE STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF RIVIPANSEL (PF-06460031) IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS | ||||
Brief Summary | The purpose of this study is to determine the effect of renal impairment on rivipansel. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other | ||||
Condition ICMJE |
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Intervention ICMJE | Drug: Rivipansel
A single 840mg dose of Rivipansel over 20 minutes Other Name: GMI-1070 | ||||
Study Arms ICMJE |
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Publications * | Tammara BK, Ryan K, Plotka A, Shafer FE, Wei H, Readett D, Fang A, Korth-Bradley JM. Effect of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intravenous Rivipansel. Clin Pharmacol Drug Dev. 2020 Nov;9(8):918-928. doi: 10.1002/cpdd.842. Epub 2020 Jun 24. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 28 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | February 2018 | ||||
Actual Primary Completion Date | February 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02813798 | ||||
Other Study ID Numbers ICMJE | B5201005 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | GlycoMimetics Incorporated | ||||
Study Sponsor ICMJE | GlycoMimetics Incorporated | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | GlycoMimetics Incorporated | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |